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Prolonged-Release Oxycodone/Naloxone Improves Anal Sphincter Relaxation Compared to Oxycodone Plus Macrogol 3350.
Dig Dis Sci. 2017 11; 62(11):3156-3166.DD

Abstract

BACKGROUND

Opioid analgesics inhibit anal sphincter function and contribute to opioid-induced bowel dysfunction (OIBD). However, it is unknown whether the inhibition can be reduced by opioid antagonism with prolonged-release (PR) naloxone and how this compares to laxative treatment.

AIMS

To compare the effects of combined PR oxycodone/naloxone or PR oxycodone plus macrogol 3350 on anal sphincter function and gastrointestinal symptoms.

METHODS

A randomized, double-blind, crossover trial was conducted in 20 healthy men. Participants were treated for 5 days with combined PR oxycodone/naloxone or PR oxycodone plus macrogol 3350. Resting anal pressure, anal canal distensibility, and relaxation of the internal sphincter to rectal distension were evaluated before treatment (baseline) and on day 5. The Patient Assessment of Constipation Symptom (PAC-SYM) questionnaire, stool frequency, and stool consistency were assessed daily.

RESULTS

Both PR oxycodone/naloxone and PR oxycodone plus macrogol treatment decreased sphincter relaxation compared to baseline (- 27.5%; P < 0.001 and - 14.7%; P = 0.01). However, sphincter relaxation was increased after PR naloxone/oxycodone treatment compared to macrogol (difference = + 17.6%; P < 0.001). Resting anal pressure and anal canal distensibility did not differ between treatments. PAC-SYM abdominal symptoms score was lower during PR naloxone compared to macrogol (0.2 vs. 3.2; P = 0.002). The number of bowel movements was lower during PR naloxone versus macrogol (4.2 vs. 5.4; P = 0.035).

CONCLUSION

Relaxation of the internal anal sphincter was significantly better after PR oxycodone/naloxone treatment compared to PR oxycodone plus macrogol 3350. These findings highlight that OIBD may require specific therapy against the complex, pan-intestinal effects of opioids.

Authors+Show Affiliations

Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Mølleparkvej 4, 9000, Aalborg, Denmark.Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Mølleparkvej 4, 9000, Aalborg, Denmark. Department of Drug Design and Pharmacology, University of Copenhagen, Universitetsparken 2, 2100, Copenhagen, Denmark.Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Mølleparkvej 4, 9000, Aalborg, Denmark.GIOME Academia, Department of Clinical Medicine, Aarhus University, Nordre Ringgade 1, 8000, Aarhus, Denmark.GIOME, Department of Surgery, Prince of Wales Hospital, Chinese University of Hong Kong, Shatin, Hong Kong.Neurogastroenterology Unit, Department of Hepatology and Gastroenterology, Aarhus University Hospital, Nørrebrogade 44, 8000, Aarhus, Denmark.Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Mølleparkvej 4, 9000, Aalborg, Denmark. amd@rn.dk. Department of Clinical Medicine, Aalborg University, Sdr. Skovvej 15, 9000, Aalborg, Denmark. amd@rn.dk.

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

28986667

Citation

Poulsen, Jakob Lykke, et al. "Prolonged-Release Oxycodone/Naloxone Improves Anal Sphincter Relaxation Compared to Oxycodone Plus Macrogol 3350." Digestive Diseases and Sciences, vol. 62, no. 11, 2017, pp. 3156-3166.
Poulsen JL, Brock C, Grønlund D, et al. Prolonged-Release Oxycodone/Naloxone Improves Anal Sphincter Relaxation Compared to Oxycodone Plus Macrogol 3350. Dig Dis Sci. 2017;62(11):3156-3166.
Poulsen, J. L., Brock, C., Grønlund, D., Liao, D., Gregersen, H., Krogh, K., & Drewes, A. M. (2017). Prolonged-Release Oxycodone/Naloxone Improves Anal Sphincter Relaxation Compared to Oxycodone Plus Macrogol 3350. Digestive Diseases and Sciences, 62(11), 3156-3166. https://doi.org/10.1007/s10620-017-4784-7
Poulsen JL, et al. Prolonged-Release Oxycodone/Naloxone Improves Anal Sphincter Relaxation Compared to Oxycodone Plus Macrogol 3350. Dig Dis Sci. 2017;62(11):3156-3166. PubMed PMID: 28986667.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Prolonged-Release Oxycodone/Naloxone Improves Anal Sphincter Relaxation Compared to Oxycodone Plus Macrogol 3350. AU - Poulsen,Jakob Lykke, AU - Brock,Christina, AU - Grønlund,Debbie, AU - Liao,Donghua, AU - Gregersen,Hans, AU - Krogh,Klaus, AU - Drewes,Asbjørn Mohr, Y1 - 2017/10/06/ PY - 2017/03/16/received PY - 2017/09/27/accepted PY - 2017/10/8/pubmed PY - 2017/11/7/medline PY - 2017/10/8/entrez KW - Anal sphincter KW - Constipation KW - Opioids: adverse effects KW - Rectoanal inhibitory reflex SP - 3156 EP - 3166 JF - Digestive diseases and sciences JO - Dig. Dis. Sci. VL - 62 IS - 11 N2 - BACKGROUND: Opioid analgesics inhibit anal sphincter function and contribute to opioid-induced bowel dysfunction (OIBD). However, it is unknown whether the inhibition can be reduced by opioid antagonism with prolonged-release (PR) naloxone and how this compares to laxative treatment. AIMS: To compare the effects of combined PR oxycodone/naloxone or PR oxycodone plus macrogol 3350 on anal sphincter function and gastrointestinal symptoms. METHODS: A randomized, double-blind, crossover trial was conducted in 20 healthy men. Participants were treated for 5 days with combined PR oxycodone/naloxone or PR oxycodone plus macrogol 3350. Resting anal pressure, anal canal distensibility, and relaxation of the internal sphincter to rectal distension were evaluated before treatment (baseline) and on day 5. The Patient Assessment of Constipation Symptom (PAC-SYM) questionnaire, stool frequency, and stool consistency were assessed daily. RESULTS: Both PR oxycodone/naloxone and PR oxycodone plus macrogol treatment decreased sphincter relaxation compared to baseline (- 27.5%; P < 0.001 and - 14.7%; P = 0.01). However, sphincter relaxation was increased after PR naloxone/oxycodone treatment compared to macrogol (difference = + 17.6%; P < 0.001). Resting anal pressure and anal canal distensibility did not differ between treatments. PAC-SYM abdominal symptoms score was lower during PR naloxone compared to macrogol (0.2 vs. 3.2; P = 0.002). The number of bowel movements was lower during PR naloxone versus macrogol (4.2 vs. 5.4; P = 0.035). CONCLUSION: Relaxation of the internal anal sphincter was significantly better after PR oxycodone/naloxone treatment compared to PR oxycodone plus macrogol 3350. These findings highlight that OIBD may require specific therapy against the complex, pan-intestinal effects of opioids. SN - 1573-2568 UR - https://www.unboundmedicine.com/medline/citation/28986667/Prolonged_Release_Oxycodone/Naloxone_Improves_Anal_Sphincter_Relaxation_Compared_to_Oxycodone_Plus_Macrogol_3350_ L2 - https://doi.org/10.1007/s10620-017-4784-7 DB - PRIME DP - Unbound Medicine ER -